STAT+: FDA digital health leader promises generative AI regulatory guidance is coming

The Food and Drug Administration announced it is developing a plan to regulate medical devices incorporating generative artificial intelligence, with formal policy guidance to come. Rick Abramson, director of the FDA’s Digital Health Center of Excellence, told STAT that the agency aims to provide clarity to the ecosystem, which is expecting concrete rules. In addition to broad guidance on generative AI as a whole, the FDA plans to issue narrower, specialty guidance on particular generative AI topics of special interest or complexity. No timeline was specified.